Click here for search
user-alt user-alt Member Login Join
folder folder (1) News Media Resources map-marker-alt map-marker-alt-1 Find a Compounding Pharmacy
user-alt Member Login Join
Click here for search
Events

Events

Upcoming APC events

Events Calendar
APC hosts three big events each year
Compounders on Capitol Hill
APC’s annual D.C. fly-in is your best chance all year to meet with federal legislators on their turf. Share your concerns and brief them on the issues facing your compounding practice in this two-day networking event.
EduCon
Our annual education conference in collaboration with the Ohio Pharmacists Association focuses on a different timely issue or topic each year.
Owner Summit
A one-of-a-kind learning, planning, and networking especially for compounding pharmacy leaders. Two days of meaty presentations and conversations focused on helping you run your business better.
Advocacy

Advocacy

Get Involved
Protecting pharmacy compounding—and the patients it serves
Federal Advocacy
Lobbying on Capitol Hill to assure that legislation elevates and preserves pure ingredient compounding
State Level Resources
APC has three members-only resources covering state-level compounding issues. Plus, find what we are working on.
CompPac
Help elect candidates who think like you do about pharmacy compounding.
APC Position Statements
From time to time, APC makes its position clear on critical issues related to compounding.
Patient Reported Outcomes
Because a lack of data hurts our position with FDA
Education

Education

Being an exceptional compounding professional means you never stop learning

On-Demand Courses Live Courses
Ethical Compounding
There’s an old saying, “You can’t talk your way out of a problem you behaved your way into.”
Compounding Foundations Course
The Ethical, Legal, and Regulatory Foundations of Pharmacy Compounding
CE Courses
Keeping you at the top of your game
Compounding Best Practices
In 2024, APC formed a ‘Best-Practices Working Group’ to look at critical issues and to offer a defined, science-based practice for compounding certain medications and for other critical processes.
News
About

About

Committed to pharmacy compounding

Membership Opportunities
What We Stand For
Learn about the Alliance for Pharmacy Compounding's mission to protect patient access to compounded medications and advocate for fair regulation of compounding practices.
Leadership
Meet the volunteer board of directors and executive committee leading the Alliance for Pharmacy Compounding.
APC Professional Staff
Get to know the professional staff at the Alliance for Pharmacy Compounding.
APC Fellowship
Learn about the APC Fellowship Program, recognizing pharmacists and technicians for exemplary professionalism in pharmacy compounding.
PCF Leadership
Discover the leadership of the Pharmacy Compounding Foundation, APC’s educational non-profit arm.
Contact

FDA’s flawed memorandum of understanding on interstate shipments

document_sign

The latest

UPDATE: On February 23, 2022, FDA conceded that it must conduct formal notice-and-comment rulemaking to implement the MOU. The agency said it would suspend implementation of the MOU and engage in a formal rulemaking process, and it indicated in its filing that the process may take “several years” to complete. Read the full story here, in APC's press release.

PREVIOUSLY: On September 21, 2021, U.S. District Court Judge Christopher Cooper issued a summary judgment in favor of a group of compounding pharmacies, ruling that FDA’s MOU on interstate shipments of compounded drugs violated the law, and the agency cannot enforce it.  The MOU was remanded back to FDA, and the agency must “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”

The background

In 1997, as part of the Food, Drug & Cosmetic Act, FDA was instructed to draft a memorandum of understanding with states regarding the interstate shipment of compounded drugs. It was expected to be a consensus document, created with input and endorsement of the states — an MOU they would be willing to sign.

Instead, inexplicably, the FDA drafted the MOU with little input from state boards of pharmacy, and released a document that, rather than having broad backing, puts states between a rock and a hard place:

  1. They can sign the MOU and commit to investigating, documenting, and reporting to FDA any time a pharmacy ships more than 50 percent of its compounded drugs to out-of-state patients.
  2. Don’t sign, and limit every pharmacy in the state to shipping no more than five percent of their prescription orders to other states.

Resources and information

 

Layer_1 (1)

Pharmacy compounding continues to be threatened by ill-conceived regulation, making APC’s role even more important. We advocate for sensible, science-based regulation and will continue to fight overreach by regulatory agencies that hinders patient access to physician-prescribed compounded medications.

For more information on our current priorities:
Click here